Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-27 @ 2:33 AM
Study NCT ID:
NCT04951050
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-09
First Post:
2021-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment
Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Single-arm Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in Patients With Coronary Artery Stenosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T-P
Brief Summary:
The aim of the TARGET PREMIER trail in to demonstrate the safety and efficacy of the rapamycin target eluting stent in the treatment of subjects with ischemic heart disease (asymptomatic myocardial ischemia , table or unstable angina), with target lesion(s) in coronary arteries with visually estimated reference vessel diameter ≥2.25mm and ≤4.0 mm.
Detailed Description:
200 participants with coronary artery stenosis will enrolled in the investigation to receive PCI surgery treatment with rapamycin target eluting stent implantation. All the participants will get clinical follow-up after PCI surgery within 30 days, 6 months, 9 months, 12 months and 2-5 years, and they will be conducted coronary angiogram at 9th month after PCI to get the data of in-stent late loss which was the main endpoint of the investigation. The secondary endpoints including device sucess, operation success, clinical sucess, Doce, PoCE, TLR, TVR, MI incident rate, death, stent thrombosis as defined by ARC, stent retraction, MLD, DS and ARB. The data derived from the investigation will be performed statistic analysis to evaluate whether the clinical outcome meet the PG.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: